MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-12-19 for PERIFIX SOFT TIP N/A PCK-626J-1 manufactured by B. Braun Melsungen Ag.
[131767364]
(b)(4). Note: this report is being filed for an item number that is not sold in the united states, however this item or similar items are used in products that are sold in the united states by b. Braun medical, inc. We received: one used catheter and other components. Visual inspection of the catheter: the catheter is broken off 89mm away from the tip. There was a scratch mark on the broken of cross section. The fault could be reconstructed in a test "example of contact and damage of puncture needle and catheter": the catheter was pulled out after pushing the cannula tip while applying a light force so as to cut into the catheter. The broken catheter was reproduce. Visual inspection of the needle tip: there was slight damage. There were no abnormalities such as bending or damage in other parts. Review manufacturing record: we checked our manufacturing records and any abnormality was not found. No abnormality was found in the catheter acceptance inspection result. Justification: the fault could be reconstructed. According to customer, defect was found after operation. So, there was no damage on catheter before use. This complaint was not confirmed.
Patient Sequence No: 1, Text Type: N, H10
[131767465]
As reported by the user facility ((b)(4)): catheter was broken off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2018-00277 |
| MDR Report Key | 8179348 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-12-19 |
| Date of Report | 2018-12-19 |
| Date of Event | 2018-11-26 |
| Date Facility Aware | 2018-12-19 |
| Report Date | 2018-12-19 |
| Date Reported to FDA | 2018-12-19 |
| Date Reported to Mfgr | 2018-12-19 |
| Date Mfgr Received | 2018-11-27 |
| Date Added to Maude | 2018-12-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JONATHAN SEVERINO |
| Manufacturer Street | 861 MARCON BLVD. |
| Manufacturer City | ALLENTOWN PA 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 4842408332 |
| Manufacturer G1 | B. BRAUN MELSUNGEN AG |
| Manufacturer Street | CARL-BRAUN-STR. 1 |
| Manufacturer City | MELSUNGEN, 34212 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 34212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERIFIX SOFT TIP |
| Generic Name | EPIDURAL CATHETER |
| Product Code | DQR |
| Date Received | 2018-12-19 |
| Returned To Mfg | 2018-12-13 |
| Model Number | N/A |
| Catalog Number | PCK-626J-1 |
| Lot Number | 18G21H82YH |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MELSUNGEN AG |
| Manufacturer Address | CARL-BRAUN-STR. 1 MELSUNGEN, HESSEN 34212 GM 34212 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-19 |